Expired Study
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San Diego, California 92161


Purpose:

Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider.


Study summary:

Background: Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider Objectives: The objective of this proposal is to explore the feasibility and initially evaluate the potential efficacy of a video teleconferencing system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient- centered, collaborative management for patients who are prescribed the gold-standard treatment, continuous positive airway pressure (CPAP). Methods: The evaluative aspect of this proposal was designed as a pilot randomized, controlled clinical trial of Video Teleconferencing (VTC) compared to Usual Care (UC). The key feature of the Video Teleconferencing intervention was the use of a telemedicine system that allows for audio/visual conferencing with the patient in their home environment from the start of treatment initialization. The provider is able provide more direct feedback to the patient based on the telemedicine interaction, and the patient benefits from increased contact with the provider. Specific inclusion and exclusion criteria included: age > 18 years; confirmed diagnosis of moderate-severe OSA; being newly prescribed CPAP therapy; having chronic symptoms as noted on screening symptom checklist; and fluency in English. Patients were recruited from the VA San Diego Healthcare System Pulmonary Sleep Clinic. Patients were enrolled for a 2-month time period. Groups were compared on quantitative and qualitative measures. Status: Study Complete


Criteria:

Inclusion Criteria: - Diagnosed with Moderate to Severe Sleep Apnea - Live in San Diego County - Veteran Exclusion Criteria: - Previous use of positive pressure airway therapy - Residence outside of San Diego county


Study is Available At:


Original ID:

PPO 10-101


NCT ID:

NCT01259440


Secondary ID:

H130392


Study Acronym:


Brief Title:

Using Telemedicine to Improve Veteran Sleep Apnea Care


Official Title:

Using Telemedicine to Improve Veteran Sleep Apnea Care


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Carl J Stepnowsky, PhD
Principal Investigator
San Diego Veterans Healthcare System

Study Dates

Start Date:August 2011
Completion Date:May 2012
Completion Type:Actual
Primary Completion Date:March 2012
Primary Completion Type:Actual
Verification Date:August 2014
Last Changed Date:August 11, 2014
First Received Date:December 10, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Treatment Adherence
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Usual Care
Description:Consists of one week telephone call and one month clinic visit
Arm Name:Arm 2
Intervention Type:Behavioral
Name:Video Teleconferencing Care
Description:The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
Arm Name:Arm 1

Study Arms

Study Arm Type:Active Comparator
Arm Name:Arm 1
Description:Video teleconferencing care
Study Arm Type:Placebo Comparator
Arm Name:Arm 2
Description:Usual Care

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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